Biosimilars are highly similar, comparable version of biologics, which undergo clinical trials to demonstrate that they have comparable safety, quality and efficacy to an approved biologic medicine. When the patent of the original product expires, biosimilars can be manufactured which are approved officially. Moreover, biologics are more complex than biosimilar drugs, both in composition and method of manufacture. Biosimilars will not be exact replicas of an approved biologic medicine but may instead show high similarity. Furthermore, in the United States, approximately 45%, i.e. 133 million of people have suffered with at-least one chronic disease. According to National Cancer Institute of America, in 2017 the national expenditures for cancer care was USD 147.3 billion. Whereas, in 2018, 3.9 million new cases of cancer and over 1.9 million cancer deaths were estimated in Europe. Hence, the high prevalence of chronic diseases such as cancer, growth hormone deficiency and anemia is projected to fuel the demand of biosimilars in near future. Additionally, Biologics and biosimilars frequently require special handling such as refrigeration and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream.
The global biosimilars market is driven by key factors such as rising incidence of chronic diseases, the emergence of off-patent biologic products and innovative strategies in enhanced productivity and clinical trial activities for biosimilars. Furthermore, these drugs are very cost-effective thus making its demand to increase significantly. However, factors such as lack of regulatory guidelines, high capital required for research & development, complications in manufacturing and lengthy clinical trials which are required from the regulatory bodies for approval are hampering the biosimilars market globally. Whereas, factors such as patent expiry of biologic products and new market potential in developing countries are some opportunities for this market.
The biosimilars market is segmented by technology, product, disease, type and geography
The major technology of the biosimilar market includes monoclonal antibodies technology, recombinant DNA technology, chromatography, nuclear magnetic resonance technology, electrophoresis, mass spectrometry, western blotting and bioassay. Whereas, chromatography is bifurcated into protein sequencing, liquid chromatography and gas chromatography. Likewise, electrophoresis is divided into gel electrophoresis and capillary electrophoresis. A series of procedures that are used to join together (recombine) DNA segments. A recombinant DNA molecule is constructed from segments of two or more different DNA molecules. Under certain conditions, a recombinant DNA molecule can enter a cell and replicate there, either on its own or after it has been integrated into a chromosome.
Based on product the biosimilar market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins and peptides. Further, recombinant non-glycosylated proteins is bifurcated into human growth hormone, insulin, interferon and granulocyte colony stimulating factor (G-CSF). Whereas, recombinant glycosylated proteins is sub-segmented into erythropoietin, monoclonal antibodies and follitropin. Among these, recombinant non-glycosylated proteins dominated the global market in 2018, owing to rising regulatory approvals.
Various disease were studied in this report which includes Oncology, Chronic Diseases, Autoimmune Diseases, Blood Disorders, Growth Hormone Deficiency and Infectious Diseases. The oncology segment dominated the global biosimilars market in 2018. This is due to high prevalence rate of chronic disease such as cancer, rising incidence of blood disorders across the globe, low cost of biosimilars compared to biologics.
Based on type the biosimilars market is segmented into in-house manufacturing and contract manufacturing. The in-house manufacturing segment accounted for the largest share in 2018. The in-house method of manufacturing is first choice of biosimilar manufacturers as they can develop biosimilars in their own laboratories, this can exclude shipping and delivery costs.
The biosimilars market report is studied across the key countries of North America, Europe, Asia Pacific and Rest of the World. The Europe dominated the biosimilars market in 2018, owing to the rising geriatric population, successive increase in the incidence of age-related disorders and chronic disorders. However, Asia-Pacific is anticipated to be the fastest-growing region for the biosimilars market.
The key players operating in the biosimilars market includes Sandoz, Pfizer, Teva Pahrmaceutical, Biocon, Amgen, Samsung Biologics, Mylan, Dr. Reddy's Laboratories, Stada Arzneimittel AG, Genentech (Roche Group), Merck Serono (Merck Group), Celltrion Healthcare and AbbVie Inc. Leading companies have invested massive capital in research & development and mergers & acquisitions activities to develop innovative products in the market.
The biosimilars market is segmented by technology, product, disease, type and geography. The major technology of the Biosimilar market includes monoclonal antibodies technology, recombinant DNA technology, chromatography, nuclear magnetic resonance technology, electrophoresis, mass spectrometry, western blotting and bioassay. Whereas, Chromatography is bifurcated into protein sequencing, liquid chromatography and gas chromatography. Likewise, electrophoresis is divided into gel electrophoresis and capillary electrophoresis. A series of procedures that are used to join together (recombine) DNA segments. A recombinant DNA molecule is constructed from segments of two or more different DNA molecules. Under certain conditions, a recombinant DNA molecule can enter a cell and replicate there, either on its own or after it has been integrated into a chromosome. Based on product the Biosimilar market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins and peptides. Further, recombinant non-glycosylated proteins is bifurcated into human growth hormone, insulin, interferon and granulocyte colony stimulating factor (g-csf). Whereas, recombinant glycosylated proteins is sub-segmented into erythropoietin, monoclonal antibodies and follitropin. Among these, recombinant non-glycosylated proteins dominated the global market in 2018, owing to rising regulatory approvals. Various disease were studied in this report which includes oncology, chronic diseases, autoimmune diseases, blood disorders, growth hormone deficiency and infectious diseases. The oncology segment dominated the global biosimilars market in 2018. Based on type the biosimilars market is segmented into in-house manufacturing and contract manufacturing. The in-house manufacturing segment accounted for the largest share in 2018. The in-house method of manufacturing is first choice of Biosimilar manufacturers as they can develop biosimilars in their own laboratories. The biosimilars market report is studied across the key countries of North America, Europe, Asia Pacific and Rest of the World. The Europe dominated the biosimilars market in 2018, owing to the rising geriatric population and the successive increase in the incidence of age-related disorders and chronic disorders.
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